化膿性中耳炎に対するT-2588とCefaclorの二重盲検比較試験成績

抄録

For the purpose of evaluating the clinical efficacy, safety and utility of T-2588 (a novel oral cephem of ester type) for suppurative otitis media, a comparative double blind study was carried out by using Cefaclor (CCL) as a control drug. Patients over 15 years old with suppurative otitis media were orally administered T-2588 (3×200mg/day) or CCL (3×250mg/day) for 7 days. 1. In the evaluation of clinical efficacy by a committee, the efficacy rate was 56.0% for the T-2588 group and 53.8% for the CCL group. There was no significant difference between these efficacy rates. No significant difference was observed in the evaluation of clinical efficacy by the attending physician. 2. On day 7 after initiation of treatment, the overall improvement rate was 49.5% and 41.9% in the T-2588 group and CCL group, respectively. There was no significant difference between the two groups. 3. The bacteriological effect (elimination rate), judged by a committee, of T-2588 group and CCL group were 62.2% and 65.4%, respectively. No significant difference was noted in the two groups. 4. The attending physicians rated as “satisfactory” or “markedly satisfactory” 53.8% of the T-2588 group and 57.0% of the CCL group. There was no significant difference between the two groups. 5. Side effects were observed in 4 (3.9%) of 102 cases in the T-2588 group and 3 (2.8%) of 106 cases in the CCL group. There was no significant difference between the two groups. These results indicate that T-2588 as well as CCL are useful drugs for the treatment of suppurative otitis media.